Antiarrhythmic and tranquilizer composition and treatment

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C514S415000, C514S574000, C514S821000

Reexamination Certificate

active

06620836

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a composition and method of treatment of cardiac arrhythmia.
2. Description of the Prior Art
A cardiac condition which has long puzzled heart specialists is atrial fibrillation, which is abbreviated herein and in the medical profession as AF. The condition of AF can be described as an irregular and very rapid heart beat. In extreme cases it may result in sudden death.
AF is an extreme form of cardiac arrhythmia. Cardiac arrhythmia is the condition in a subject of an irregular heart beat. The heart of a subject having a condition of cardiac arrhythmia departs from the normal, rhythmic pulsing produced by the contraction and relaxation of the heart muscles, and instead pulses in an erratic manner. Indeed, in an arrhythmic subject the heart may pause for as long as several seconds, neither contracting nor relaxing. Such a pause is typically followed by a few very rapid heartbeats.
Persons considered to be medically normal and healthy may experience cardiac arrhythmia, especially during stress or exercise. Cardiac arrhythmia is also typical in cases of acute alcoholism and after surgery. However, although cardiac arrhythmia may be tolerated by a subject for many years, the condition of cardiac arrhythmia usually precedes or is a contributing factor to AF which is a much more dangerous condition. Persistent AF usually occurs in patients with rheumatic heart disease, microvalve disease, hypertension, or thyroidtoxicosis (Taber's Cyclopedic Medical Dictionary). Regarding treatment, Tabor's advises that the patient should be instructed concerning optimum physical function by utilizing frequent rest periods and the need to restrict sodium intake, and also instructed concerning drugs that are prescribed.
A widespread view among many physicians is that body functions, including cardiac arrhythmia, should be controlled through the use of drugs. Such drugs have been administered under the mistaken view that they prevent cardiac arrest and death. As disclosed in the recent book
Deadly Medicine
by Thomas J. Moore, Simon & Schuster, the administration of drugs intended to treat cardiac arrhythmia is thought to have induced the premature death, in just a few years, of an estimated 50,000 people. Such drugs continue to be administered despite a definitive medical experiment, as reported by Moore and financed by the U.S. Government, that has proven that such drugs do not prevent cardiac arrest, but in fact cause it. As stated by Moore, the effect of these drugs was so sudden and unexpected that people literally dropped dead while going about their normal lives. According to him, “The result of the single medical misjudgment about the proper use of these drugs has produced a death toll larger than the United States combat losses in wars such as Korea and Viet Nam.”
SUMMARY OF THE INVENTION
The present invention is a composition and method of treatment of cardiac arrhythmia which avoids the use of conventional drugs, but instead relies upon a composition, one of the principal active components of which is generated in the human body itself. This component is the natural hormone melatonin.
Melatonin is a hormone produced by the pineal gland of the body. The production of melatonin is induced by the perception of darkness as transmitted from the eyes to the pineal gland between the two hemispheres of the brain. The pineal gland of a normal person produces approximately 500 mcg (micrograms) of melatonin daily. However, starting at age 12, or even earlier, production of this key hormone goes into steady decline. In an octogenarian the amount of melatonin produced is quite nominal. Whereas at one time the pituitary gland was thought of as being the master gland of the body, it is now becoming increasingly evident that the pineal gland is truly the master gland, and that the decline in the output of melatonin is clearly an aspect of aging. Melatonin is known to be a sleep inducing substance. Indeed, melatonin is sold commercially in sublingual and in tablet form in which each tablet contains about 2.5 mg to 5.0 mg of melatonin as a treatment for insomnia.
The powerful drugs with possibly dangerous, even fatal side effects that are conventionally used for the treatment of cardiac arrhythmia can be replaced with a composition according to my invention. This composition includes melatonin potentiated with compounds of magnesium and preferably including the mineral ascorbates of calcium, magnesium, and zinc. By using my composition conventional antiarrhythmic drugs can be replaced entirely in the treatment of cardiac arrhythmia.
I have discovered that melatonin, when taken in suitable form and at a relatively low strength, in combination with any one or more of a number of different compounds of magnesium, substantially reduces cardiac arrhythmia. This is especially true when the hormone is taken in sublingual form at a low level, preferably at strength of between about 25 micrograms and about 10 milligrams.
I have further discovered that although melatonin by itself is beneficial and useful for treating cardiac arrhythmia, it is much more effective when combined with other substances. Specifically, I have found that the combination of melatonin at a strength of between about 25 micrograms and 10 milligrams, in combination with a magnesium compound, administered sublingually, is extremely beneficial in treating cardiac arrhythmia. Preferably the magnesium is combined with melatonin in the form of calcium magnesium ascorbate, magnesium citrate, magnesium niacinate, or a combination of these magnesium compounds. Other magnesium compounds, such as magnesium aspartate or magnesium orotate may be used in addition or as substitutes.
The combination of magnesium with melatonin has several effects which are not readily apparent. Calcium and magnesium are essential to the function of the heart. The heart muscle cannot contract without calcium, and cannot relax without magnesium.
In the conventional treatment of heart disease, which is often characterized or accompanied by cardiac arrhythmia, calcium channel blockers have gained wide-spread use. However, when persons take such drugs the calcium in their systems is not adequately-opposed by the muscle relaxing magnesium. I regard this as a backward approach, in that more should be done to increase the magnesium which is essential to the relaxation of the heart muscle, rather than to cut down on the action of the calcium. The action of these electrolytes must be well balanced for the heart to function normally for many years of service.
Rather than using calcium channel blockers to hold off the sometimes frenzied action of calcium, I believe that the combination of magnesium with melatonin has a synergistic effect in the relaxation of the heart muscle. Indeed, this action is so positive that users have reported that the modulating effect can be felt within minutes after the product is dissolved in the mouth. Thus, a composition containing melatonin in combination with magnesium treats cardiac arrhythmia by promoting the relaxation of the heart muscle through the use of both melatonin and magnesium, as contrasted to the conventional approach of attempting to promote relaxation by reducing the action of calcium on the heart muscle.
The combination of magnesium with melatonin in the form of magnesium citrate also has another beneficial effect which is not readily apparent. It is well established that melatonin slows the digestive process, as noted in the book
Melatonin Miracle
, by Drs. Walter Pierpaoli and William Regelson. Indeed, one of the adverse side effects of the commercially available melatonin sleep inducing tablets that are commercially available is constipation. This is a problem which is well documented in the literature. By augmenting melatonin with magnesium citrate the constipating effect of melatonin is reduced.
A further beneficial substance which is preferably combined with the magnesium and magnesium citrate is vitamin C (calcium magnesium ascorbate). T

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